Abstract:

Mitral valve prolapse and mitral regurgitation can be treating by
implanting in the mitral annulus a transvalvular intraannular band having
an elongate and arcuate body. The elongate and arcuate body has a first
end, a first anchoring portion located proximate the first end, a second
end, a second anchoring portion located proximate the second end, and a
central portion. The central portion is displaced from the plane
containing the first end and the second end. The transvalvular band is
positioned so that it extends transversely across a coaptive edge formed
by the closure of the mitral valve leaflets and the central portion is
displaced towards the left ventricle relative to the first anchoring
portion and the second anchoring portion. The ventricular direction
displacement moves coaption to an earlier point in the cardiac cycle.

Claims:

1. A transvalvular intraannular band, the transvalvular band comprising:an
elongate and arcuate body having a first end, a first anchoring portion
located proximate the first end, a second end, a second anchoring portion
located proximate the second end, and a central portion, the central
portion displaced transversely from a plane which includes the first end
and the second end;wherein the first end and the second end are
configured to be attached to the mitral valve annulus within the plane of
the annulus and the central portion is configured to support the mitral
valve leaflets at a point displaced toward the ventricle from the plane.

2. The transvalvular band of claim 1, wherein the central portion is
narrower than both the first anchoring portion and the second anchoring
portion.

3. The transvalvular band of claim 1, wherein the central portion
comprises an offset support portion and a first arm portion and a second
arm portion, the offset support portion wider than the first arm portion
and second arm portion.

4. The transvalvular band of claim 1, wherein the central portion has a
substantially triangular cross-section.

5. The transvalvular band of claim 1, wherein the first anchoring portion
extends in a lateral direction.

6. The transvalvular band of claim 5, wherein the second anchoring portion
extends in a lateral direction.

7. The transvalvular band of claim 5, wherein the first anchoring portion
has a generally arcuate shape.

8. The transvalvular band of claim 7, wherein the second anchoring portion
has a generally arcuate shape.

Description:

PRIORITY CLAIM

[0001]This application claims priority under 35 U.S.C. §120 as a
divisional application of U.S. patent application Ser. No. 12/104,011
filed Apr. 16, 2008, currently pending, which is hereby incorporated by
reference in its entirety.

BACKGROUND OF THE INVENTION

[0002]1. Field of the Invention

[0003]Embodiments of the present invention relate generally to treatment
of mitral or tricuspid valve prolapse and mitral regurgitation, and more
specifically, relate to the use of a transannular band to treat mitral
valve prolapse and mitral regurgitation.

[0004]2. Description of the Related Art

[0005]The heart is a double (left and right side), self-adjusting muscular
pump, the parts of which work in unison to propel blood to all parts of
the body. The right side of the heart receives poorly oxygenated
("venous") blood from the body from the superior vena cava and inferior
vena cava and pumps it through the pulmonary artery to the lungs for
oxygenation. The left side receives well-oxygenated ("arterial") blood
from the lungs through the pulmonary veins and pumps it into the aorta
for distribution to the body.

[0006]The heart has four chambers, two on each side--the right and left
atria, and the right and left ventricles. The atria are the
blood-receiving chambers, which pump blood into the ventricles. A wall
composed of membranous and muscular parts, called the interatrial septum,
separates the right and left atria. The ventricles are the
blood-discharging chambers. A wall composed of membranous and muscular
parts, called the interventricular septum, separates the right and left
ventricles.

[0007]The synchronous pumping actions of the left and right sides of the
heart constitute the cardiac cycle. The cycle begins with a period of
ventricular relaxation, called ventricular diastole. The cycle ends with
a period of ventricular contraction, called ventricular systole.

[0008]The heart has four valves that ensure that blood does not flow in
the wrong direction during the cardiac cycle; that is, to ensure that the
blood does not back flow from the ventricles into the corresponding
atria, or back flow from the arteries into the corresponding ventricles.
The valve between the left atrium and the left ventricle is the mitral
valve. The valve between the right atrium and the right ventricle is the
tricuspid valve. The pulmonary valve is at the opening of the pulmonary
artery. The aortic valve is at the opening of the aorta.

[0009]Various disease processes can impair the proper functioning of one
or more of these valves. These include degenerative processes (e.g.,
Barlow's Disease, fibroelastic deficiency), inflammatory processes (e.g.,
Rheumatic Heart Disease) and infectious processes (e.g., endocarditis).
In addition, damage to the ventricle from prior heart attacks (i.e.,
myocardial infarction secondary to coronary artery disease) or other
heart diseases (e.g., cardiomyopathy) can distort the valve's geometry
causing it to dysfunction.

[0010]The mitral valve is comprised of an anterior leaflet and a posterior
leaflet. The bases of the leaflets are fixed to a circumferential partly
fibrous structure, the annulus, preventing dehiscence of the valve. A
subvalvular apparatus of chordae and papillary muscles prevents the valve
from prolapsing into the left atrium. Mitral valve disease can be
expressed as a complex variety of pathological lesions of either valve or
subvalvular structures, but can also be related to the functional status
of the valve. Functionally the mitral valve disease can be categorized
into two anomalies, increased leaflet motion i.e. leaflet prolapse
leading to regurgitation, or diminished leaflet motion i.e. restricted
leaflet motion leading to obstruction and/or regurgitation of blood flow.

[0011]Leaflet prolapse is defined as when a portion of the leaflet
overrides the plane of the orifice during ventricular contraction. The
mitral regurgitation can also develop secondary to alteration in the
annular ventricular apparatus and altered ventricular geometry, followed
by incomplete leaflet coaptation. In ischemic heart failure this can be
attributed to papillary or lateral wall muscle dysfunction, and in
non-ischemic heart failure it can be ascribed to annular dilation and
chordal tethering, all as a result of dysfunctional remodeling.

[0012]The predominant cause of dysfunction of the mitral valve is
regurgitation which produces an ineffective cardiac pump function
resulting in several deleterious conditions such as ventricular and
atrial enlargement, pulmonary hypertension and heart-failure and
ultimately death.

[0013]The main objective for the surgical correction is to restore normal
function and not necessarily anatomical correction. This is accomplished
by replacing the valve or by reconstructing the valve. Both of the
procedures require the use of cardiopulmonary bypass and is a major
surgical operation carrying a non-negligible early morbidity and
mortality risk, and a postoperative rehabilitation for months with
substantial postoperative pain. Historically, the surgical approach to
patients with functional mitral regurgitation was mitral valve
replacement, however with certain adverse consequences such as
thromboembolic complications, the need for anticoagulation, insufficient
durability of the valve, loss of ventricular function and geometry.

[0014]Reconstruction of the mitral valve is therefore the preferred
treatment for the correction of mitral valve regurgitation and typically
consists of a quadrangular resection of the posterior valve
(valvuloplasty) in combination with a reduction of the mitral valve
annulus (annuloplasty) by the means of suturing a ring onto the annulus.
These procedures are surgically demanding and require a bloodless and
well-exposed operating field for an optimal surgical result. The
technique has virtually not been changed for more than three decades.

[0015]More recently, prolapse of the valve has been repaired by anchoring
the free edge of the prolapsing leaflet to the corresponding free edge of
the opposing leaflet and thereby restoring apposition but not necessarily
coaptation. In this procedure a ring annuloplasty is also required to
attain complete coaptation.

[0016]This method commonly referred to as an edge-to-edge or "Alfieri"
repair also has certain drawbacks such as the creation of a double
orifice valve and thereby reducing the effective orifice area. Several
less invasive approaches related to the edge-to-edge technique has been
suggested, for repairing mitral valve regurgitation by placing a clip
through a catheter to suture the valve edges. However, it still remains
to conduct an annuloplasty procedure, which has not yet been resolved by
a catheter technique and therefore is to be performed by conventional
surgery, which makes the method impractical.

[0017]Notwithstanding the presence of a variety of presently available
surgical techniques and promising catheter based procedures for the
future, there remains a need for a simple but effective device and
corresponding surgical, minimally invasive or transvascular procedure to
reduce mitral valve regurgitation.

SUMMARY OF THE INVENTION

[0018]There is provided in accordance with aspect of the present
invention, a transannular band for improving cardiac function. The band
comprises an elongate and arcuate body, having a first end, a first
anchoring portion located near the first end, and a second end, having a
second anchoring portion located near the second end. A central portion
is provided, for spanning the flow path of a valve such as a mitral
valve. The central portion is displaced transversally from a plane which
includes the first end and second end. As implanted, the transverse
displacement advances the coaption point of the closed valve in the
direction of the ventricle. The first end and second end are configured
to be attached to opposing sides of a mitral valve annulus, and the
central portion is configured to support the mitral valve leaflets.

[0019]In one embodiment, the central portion is narrower than both the
first anchoring portion and the second anchoring portion, measured in a
transverse direction to blood flow.

[0020]In accordance with another aspect of the present invention, there is
provided a method of treating valve prolapse. In one implementation of
the invention, the method is optimized for treating mitral valve
prolapse.

[0021]The method comprises the steps of implanting in the mitral valve
annulus a transannular band comprising an elongate and arcuate body,
having a first end, a first anchoring portion located proximate the first
end, and a second end, having a second anchoring portion located
proximate the second end. A central portion is provided, for spanning the
blood flow path. The central portion is displaced from a plane which
includes the first end and the second end.

[0022]The first anchoring portion is attached to a first portion of the
mitral annulus, and the second anchoring portion is attached to a second
portion of the mitral annulus, such that the transannular band extends
transversely across a coaptive edge formed by the closure of the mitral
valve leaflets. The transannular band is implanted such that the central
portion is displaced in the direction of the left ventricle relative to
the first anchoring portion and the second anchoring portion.

[0023]Further features and advantages of the present invention will become
apparent to those of skill in the art in view of the detailed description
of preferred embodiments which follows, when considered together with the
attached drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0024]FIG. 1 is a simplified cross-sectional view of the heart with a
normal mitral valve during systole.

[0025]FIG. 2 is a cross-sectional view of the heart with a normal mitral
valve during diastole.

[0026]FIG. 3 is a bottom view of the normal mitral valve of FIG. 1 during
systole looking from the left atrium to the left ventricle.

[0027]FIG. 4 is a cross-sectional schematic view of the normal mitral
valve of FIG. 1 during systole, illustrating the depth of the coaption
zone.

[0028]FIG. 5 is a bottom view of the normal mitral valve of FIG. 2 during
diastole looking from the left atrium to the left ventricle.

[0029]FIG. 6 is a cross-sectional schematic view of the normal mitral
valve of FIG. 2 during diastole.

[0030]FIG. 7 is a cross-sectional view of the heart during systole showing
a mitral valve with a prolapsed anterior leaflet caused by the rupture of
the chordae tendineae attached to the anterior leaflet.

[0031]FIG. 8 is a bottom view of the mitral valve of FIG. 7 having a
prolapsed anterior leaflet looking from the left atrium to the left
ventricle.

[0032]FIG. 9 is a cross-sectional view of the heart during systole showing
a mitral valve with a prolapsed posterior leaflet caused by the rupture
of the chordae tendineae attached to the posterior leaflet.

[0033]FIG. 10 is a bottom view of the mitral valve of FIG. 9 having a
prolapsed posterior leaflet looking from the left atrium to the left
ventricle.

[0034]FIG. 11 is a cross-sectional view of the heart during systole
showing a mitral valve with anterior leaflet prolapse.

[0048]FIG. 23B shows an intraannular band formed from a length of wire.

[0049]FIGS. 24-27 are side views of other embodiments of a transannular
band.

[0050]FIG. 28 is a cross-sectional view of a heart during systole with a
transannular band implanted in the mitral annulus.

[0051]FIG. 29 is a bottom view of the mitral valve of FIG. 28 during
systole with a transannular band implanted in the mitral annulus looking
from the left atrium to the left ventricle.

[0052]FIG. 30 is a cross-sectional view of a heart during diastole with
mitral valve and a transannular band implanted in the mitral annulus.

[0053]FIG. 31 is a bottom view of the mitral valve of FIG. 30 during
diastole with a transannular band implanted in the mitral annulus looking
from the left atrium to the left ventricle.

[0054]FIG. 32 is a cross-sectional schematic view of the mitral valve of
FIG. 28 during systole with a transannular band implanted in the mitral
annulus.

[0055]FIG. 33 is a cross-sectional schematic view of the mitral valve of
FIG. 32 during systole without the transannular band implanted in the
mitral annulus.

[0056]FIG. 34 is a cross-sectional schematic view of the mitral valve of
FIG. 30 during diastole with the transannular band implanted in the
mitral annulus.

[0057]FIG. 35 is a cross-sectional schematic view of the mitral valve of
FIG. 34 during diastole without the transannular band implanted in the
mitral annulus.

[0058]FIG. 36 is a bottom view of the mitral valve during systole with
another embodiment of the transannular band implanted in the mitral
annulus looking from the left atrium to the left ventricle.

[0059]FIG. 37 is a cross-sectional view of a transannular band with a
transverse leaflet support.

[0060]FIG. 38 is a cross-sectional schematic view of the mitral valve
treated with the transannular band of FIG. 37 and an Alfieri type
procedure.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0061]FIG. 1 illustrates a cross-sectional view of the heart 10 with a
normal mitral valve 18 in systole. As illustrated, the heart 10 comprises
the left atrium 12 which receives oxygenated blood from the pulmonary
veins 14 and the left ventricle 16 which receives blood from the left
atrium 12. The mitral valve 18 is located between the left atrium 12 and
left ventricle 16 and functions to regulate the flow of blood from the
left atrium 12 to the left ventricle 16. During ventricular diastole, the
mitral valve 18 is open which allows blood to fill the left ventricle 16.
During ventricular systole, the left ventricle 16 contracts, which
results in an increase in pressure inside the left ventricle 16. The
mitral valve 18 closes when the pressure inside the left ventricle 16
increases above the pressure within the left atrium 12. The pressure
within the left ventricle 16 continues increasing until the pressure
within the left ventricle 16 exceeds the pressure within the aorta 20,
which causes the aortic valve 22 to open and blood to be ejected from the
left ventricle and into the aorta 20.

[0062]The mitral valve 18 comprises an anterior leaflet 24 and a posterior
leaflet 26 that have base portions that are attached to a fibrous ring
called the mitral valve annulus 28. Each of the leaflets 24 and 26 has
respective free edges 36 and 38. Attached to the ventricular side of the
leaflets 24 and 26 are relatively inelastic chordae tendineae 30. The
chordae tendineae 30 are anchored to papillary muscles 32 that extend
from the intraventricular septum 34. The chordae tendineae 30 and
papillary muscle 32 function to prevent the leaflets 24 and 26 from
prolapsing and enable proper coaptation of the leaflets 24 and 26 during
mitral valve 18 closure.

[0063]FIG. 2 illustrates a cross-sectional view of the heart 10 with a
normal mitral valve 18 in diastole. After the left ventricle 16 has
ejected the blood into the aorta, the left ventricle relaxes, which
results in a drop in pressure within the left ventricle 16. When the
pressure in the left ventricle 16 drops below the pressure in the aorta
20, the aortic valve 22 closes. The pressure within the left ventricle 16
continues dropping until the pressure in the left ventricle 16 is less
than the pressure in the left atrium 12, at which point the mitral valve
18 opens, as shown in FIG. 2. During the early filling phase, blood
passively fills the left ventricle 16 and this accounts for most of the
filling of the left ventricle 16 in an individual at rest. At the end of
the filling phase, the left atrium 12 contracts and provides a final kick
that ejects additional blood into the left ventricle.

[0064]FIG. 3 illustrates a bottom view of normal mitral valve 18 in
systole, looking from the left atrium and to the left ventricle. As
shown, the anterior leaflet 24 and posterior leaflet 26 are properly
coapted, thereby forming a coaptive edge 40 that forms a seal that
prevents retrograde flow of blood through the mitral valve 18, which is
known as mitral regurgitation. FIG. 4 provides a side cross-sectional
view of a normal mitral valve 18 in systole. As shown in FIG. 4, the
valve leaflets 24 and 26 do not normally cross the plane P defined by the
annulus and the free edges 36 and 38 coapt together to form a coaptive
edge 40.

[0065]FIG. 4 also illustrates a coaption zone 41. Preferably the depth of
coaption (length of zone 41 in the direction of blood flow, in which the
leaflets 24 and 26 are in contact) is at least about 2 mm or 5 mm, and is
preferably within the range of from about 7 mm to about 10 mm for the
mitral valve.

[0066]Thus, implantation of the devices in accordance with the present
invention preferably achieves an increase in the depth of coaption. At
increase of at least about 1 mm, preferably at least about 2 mm, and in
some instances an increase of at least about 3 mm to 5 mm or more may be
accomplished.

[0067]In addition to improving coaption depth, implantation of devices in
accordance with the present invention preferably also increase the width
of coaptation along the coaption plane. This may be accomplished, for
example, by utilizing an implant having a widened portion for contacting
the leaflets in the area of coaption such as is illustrated in connection
with FIGS. 19A and 19B below. A further modification of the coaptive
action of the leaflets which is accomplished in accordance with the
present invention is to achieve early coaption. This is accomplished by
the curvature or other elevation of the implant in the ventricle
direction. This allows the present invention to achieve early coaption
relative to the cardiac cycle, relative to the coaption point prior to
implantation of devices in accordance with the present invention.

[0068]FIGS. 5 and 6 illustrate normal mitral valve 18 in diastole. As
shown, the anterior leaflet 24 and posterior leaflet 26 are in a fully
opened configuration which allows blood to flow from the left atrium to
the left ventricle.

[0069]FIGS. 7 and 8 illustrate a heart 10 in systole where the anterior
leaflet 24 of the mitral valve 18 is in prolapse. Anterior leaflet 24
prolapse can be caused by a variety of mechanisms. For example, as
illustrated in FIG. 7, rupture 42 of a portion of the chordae tendineae
30 attached to the anterior leaflet 24 can cause the free edge 36 of the
anterior leaflet 24 to invert during mitral valve 18 closure. As shown in
FIG. 8, inversion 44 of the anterior leaflet 24 can prevent the mitral
valve leaflets 24 and 26 from properly coapting and forming a seal. This
situation where the free edge 36 of the anterior leaflet 24 crosses into
the left atrium 12 during mitral valve 18 closure can lead to mitral
regurgitation.

[0070]Similarly, FIGS. 9 and 10 illustrate posterior leaflet 26 prolapse
caused by a rupture of the chordae tendineae 30 attached to the posterior
leaflet 26. In this case, the posterior leaflet 26 can invert and cross
into the left atrium 12 during mitral valve 18 closure. The inversion of
the posterior leaflet 26 prevents the mitral valve leaflets 24 and 26
from properly coapting and forming a seal, which can lead to mitral
regurgitation.

[0071]Mitral regurgitation can also be caused by an elongated valve
leaflet 24 and 26. For example, an elongated anterior leaflet 24, as
shown in FIG. 11, can prevent the valve leaflets 24 and 26 from properly
coapting during mitral valve 18 closure. This can lead to excessive
bulging of the anterior leaflet 24 into the left atrium 12 and
misalignment of the free edges 36 and 38 during coaptation, which can
lead to mitral regurgitation.

[0072]One embodiment of a transannular band 50 that would improve mitral
valve leaflet 24 and 26 coaptation and prevent or reduce mitral
regurgitation is illustrated in FIGS. 12 and 13. FIG. 12 provides a top
view of the transannular band 50 while FIG. 13 provides a side view of
the transannular band 50. In this embodiment, the transannular band 50
comprises an elongate and curved structure with a first end 52, a second
end 54, a central portion 64 located between the two ends 52 and 54, and
a length that is capable of extending across the annulus. The leaflet
contact surface 56 is convex along the longitudinal axis, as best
illustrated in FIG. 13. In other embodiments, the leaflet contact surface
56 can have a different shape and profile. For example, the contact
surface 56 can be concave, straight, a combination of convex, concave
and/or straight, or two concave or straight portions joined together at
an apex. As illustrated in FIG. 12, the transannular band 50 can have a
substantially constant width between the first end 52 and the second end
54. The first end 52 has a first anchoring portion 58 and the second end
54 has a second anchoring portion 60.

[0073]The anchoring portions 58 and 60 can have holes 62 for sutures that
allow the transannular band 50 to be secured to the annulus.
Alternatively, in other embodiments the anchoring portions 58 and 60 can
have other means for securing the transannular band 50 to the annulus.
For example, the anchoring portions 58 and 60 can be made of a membrane
or other fabric-like material such as Dacron or ePTFE. Sutures can be
threaded directly through the fabric without the need for distinct holes
62. The fabric can be attached to the other portions of the transannular
band 50 by a variety of techniques. For example, the fabric can be
attached to the other portions of the transannular band 50 with the use
of an adhesive, by suturing, by tying, by clamping or by fusing the parts
together.

[0074]The central portion of the transannular band 50 can have a variety
of cross-sectional shapes, as illustrated in FIGS. 14-17. For example,
the cross sectional shape can be substantially rectangular, circular,
oblong or triangular. The edges of the transannular band 50 can be
rounded or otherwise configured so that the transannular band 50 presents
an atraumatic surface 51 to the valve leaflets. In some embodiments, the
cross-section can be oriented in a particular fashion to enhance
performance of the transannular band 50. For example as shown in FIG. 14,
a transannular band 50 with a triangular cross section can be designed so
that a relatively larger surface 56 of the triangle contacts the valve
leaflets while a lower profile leading edge 53 of the triangle opposite
the surface 51 faces the left atrium. This configuration allows a larger
surface area to make contact with and support the mitral valve leaflets,
while also presenting a more streamlined shape that provides less
resistance to blood flowing from the left atrium to the left ventricle.
Decreasing the resistance to blood flow is desirable because it can
reduce turbulence and reduce the impedance of the transannular band 50 on
the filling of the left ventricle. Similarly, the transannular bands 50
with an oblong or rectangular cross-section can be oriented to either
increase the surface area for contact with the valve leaflets, or be
oriented to reduce the resistance to blood flow.

[0075]The dimensions of the transannular band 50 will vary, depending upon
the specific configuration of the band 50 as well as the intended
patient. In general, transannular band 50 will have an axial length from
first end 52 to second end 54 within the range of from about 20 mm to
about 32 mm. In one embodiment, intended for a typical male adult, the
axial length of the transannular band 50 is about 24 mm to 26 mm. The
width of the transannular band 50 in the central zone 64 may be varied
depending upon the desired performance, as will be discussed herein. In
general, the trailing surface 51 against which leaflets will seat is
preferably large enough to minimize the risk of erosion resulting from
repeated contact between the closed leaflets and the implant. The width
of the leading edge 53 is preferably minimized, as discussed above, to
minimize flow turbulence and flow obstruction. In general, widths of the
surface 51 measured perpendicular to the flow of blood are presently
contemplated to be less than about 5 mm, and often within the range of
from about 5 mm to about 10 mm in the zone of coaptation.

[0076]In some embodiments as illustrated in FIG. 18, the central portion
64 of the transannular band 50 can be narrower in width, measured
perpendicular to blood flow than the first and second anchoring portions
58 and 60. By narrowing the central portion 64, the resistance to blood
flow can be reduced. However, narrowing the central portion 64 reduces
the surface area of the leaflet contact surface 56 that supports the
valve leaflets.

[0077]In the embodiment illustrated in FIG. 18, the narrowed central
portion 64 is separated from the first anchoring portion 58 and second
anchoring portion 60 by a first shoulder 57 and second shoulder 59. The
length of the central portion 64, between first shoulder 57 and second
shoulder 59 can be less than about 50% of the overall length of the
device, or less than about 30% of the overall length of the device if it
is desired to minimize the obstruction in the center of the flow path,
while presenting a wider transverse surface for supporting the leaflets
when the valve is closed. Alternatively, the length of the central zone
64 may be greater than 50%, and in some embodiments greater than 75% of
the overall length of the implant.

[0078]In some embodiments as illustrated in FIGS. 19A, 19B, 21 and 23, a
coaptive edge support portion 66 of the central portion 64 of the
transannular band 50 can be wider than the adjacent portions of the
transannular band 50, leading up to and potentially including the first
and second anchoring portions 58 and 60. By increasing the width and
surface area of the coaptive edge support portion 66, more support can be
provided to the valve leaflets at the coaptive edge. This increased
support can increase the width of leaflet coaption. The other portions of
the central portion 64 can remain narrow to reduce the resistance to
blood flow. The support portion 66 can be located at a fixed position or
adjustable along the transannular band so that its position can be
optimized by the surgeon and then secured at a fixed point such as by
suturing, or removed if deemed unnecessary.

[0079]In one implementation of the invention, the transannular band
comprises a first component for primary reduction and a second component
for fine adjustment. For example, the device illustrated in FIG. 19A may
be provided with an adjustable (e.g. slidable) support portion 66. The
transannular band may be positioned across the annulus as has been
described herein, and hemodynamic function of the valve may be evaluated.
The support portion 66 may thereafter be adjusted along the length of the
transannular band to treat residual leakage or otherwise optimize the
functionality of the implant such as by increasing the zone of
coaptation. The second component (e.g. support portion 66) may thereafter
be fixed with respect to the transannular band such as by sutures, clips,
adhesives, or other techniques known in the art. Alternatively, the
second portion may be separate from and connectable to the transannular
band such as stitching, clips, suturing or other technique known in the
art.

[0080]In addition, the coaptive edge support portion 66 can be offset from
the center of the transannular band 50, to reflect the asymmetry between
the anterior leaflet and the posterior leaflet. For example, the coaptive
edge support portion 66 can be positioned closer to the first anchoring
portion 58 than to the second anchoring portion 60. In certain
embodiments, the edge support portion 66 will be centered about a point
which is within the range of from about 20% to about 45% of the overall
length of the implant from the closest end.

[0081]FIG. 20 illustrates another embodiment of a transannular band 50
that is a modification of the transannular band 50 shown in FIG. 18. As
illustrated in FIG. 20, the transannular band 50 has a narrow central
portion 64 that provides relatively low resistance to blood flow.
However, the first and second anchoring portions 58 and 60 extend further
in a lateral direction, and can be arcuate to conform to the mitral valve
annulus. These laterally extended anchoring portions 58 and 60 provide
additional anchoring of the transannular band 50 and can help improve the
stability of the device after implantation. The laterally extending
anchoring portion 58 and 60 may be provided with any of a variety of
structures for facilitating anchoring to the valve annulus. For example,
they may be provided with a plurality of apertures 61, for conventional
stitching or to receive any of a variety of clips or tissue anchors. The
anchoring portions may alternatively be provided with any of a variety of
barbs or hooks, or may be provided with a fabric covering such as a
Dacron sleeve to facilitate sewing. Measured in the circumferential
direction (transverse to the longitudinal axis of the implant 50) the
laterally extending anchoring portions will have an arc length of greater
than about 5 mm, and, in some embodiments, greater than about 1 cm. Arc
lengths of at least about 2 cm, and, in some embodiments, at least about
3 cm may be utilized, depending upon the desired clinical performance.

[0082]FIG. 21 illustrates another embodiment of a transannular band 50
with the extended anchoring portions 58 and 60 and a wider, offset
coaptive edge support portion 66. This embodiment has the benefit of
additional stability provided by the extended anchoring portions 58 and
60 and enhanced support of the coaptive edge.

[0083]FIGS. 22 and 23 illustrate another embodiment of a transannular band
50 which is combined with an annular ring 68. The annular ring 68 can be
used as both a support for the transannular band 50 and, if desired, also
to help stabilize the size and shape of the mitral valve annulus itself.
In some embodiments, the annular ring 68 can be used to reduce the size
of the mitral valve annulus and to bring the mitral valve leaflets closer
together. This can be accomplished by, for example, suturing the mitral
valve annulus to an annular ring 68 of smaller diameter. In addition, the
annular ring 68 provides additional support and stability to the
transannular band 50. The anchoring portions 58 and 60 of the
transannular band 50 can be formed integrally with the annular ring 68,
or the anchoring portions 58 and 60 can be attached to the annular ring
by a variety of means, such as suturing, bonding, adhesives, stapling and
fusing. FIG. 22 discloses an embodiment with a narrow central portion 64
while FIG. 23 discloses an embodiment with a wider, offset coaptive edge
support portion 66.

[0084]FIG. 23A illustrates a further implementation of the invention,
adapted to treat ischemic mitral regurgitation with posterior
annuloplasty. A transannular band 61 is provided for spanning the leaflet
coaption plane as has been described herein. Any of the features
described in connection with other transannular bands disclosed herein
may be incorporated into the transannular band 61.

[0085]An arcuate posterior annuloplasty support 63 is connected to the
transannular band 61, and adapted to extend for an arc length along the
native annulus. In the illustrated embodiment, the support 63 extends
through an arc of approximately 180°, extending from a first
trigone attachment zone 65 to a second trigone attachment zone 67. The
attachment zones may be provided with sewing apertures, a fabric
covering, or other structure for facilitating attachment to tissue. In
general, the transannular band 61 will have dimensions similar to those
described elsewhere herein. The transverse dimension from first trigone
zone 65 to second trigone zone 67 may be varied depending upon the size
of the native annulus, but will generally be within the range of from
about 35 mm to about 45 mm.

[0086]Referring to FIG. 23B, there is illustrated a transannular band in
accordance with the present invention, formed from a single length or
several lengths of flexible wire. The bend angles and orientation of the
struts in the illustrated embodiment may be readily altered, to
accommodate the desired axes of compression which may be desirable for a
particular deployment procedure.

[0087]In general, the transannular band 71 comprises an elongate flexible
wire 73 formed into a serpentine pattern, for providing a support for the
valve leaflets as has been discussed herein. Although not illustrated in
FIG. 23B, the wire 73 may be formed such that it bows or inclines in the
direction of the ventricle to achieve early closure as is discussed
elsewhere herein. The wire 73 may extend into a first connection section
75 and a second connection section 77. Each of the connection sections 75
and 77 may be provided with a plurality of eyelets 79, to receive sutures
for attaching the implant to the valve annulus. The implant may be formed
from any of a variety of flexible materials, including various polymers
described elsewhere herein as well as Nitinol, stainless steel or other
metals known in the art. This design has an advantage of providing a
relatively large support footprint against the valve leaflets, while at
the same time optimizing the area of open space to permit maximum blood
flow therethrough.

[0088]FIGS. 24-27 illustrate side views of transannular bands 50 with
different inclinations. One of the objectives of the present invention is
to not merely provide support to the leaflets during systole, but to
elevate the plane of coaption in the direction of the ventricle, to cause
early coaption (closure) relative to the cardiac cycle, as is discussed
elsewhere herein. The variation in conditions, and other patient to
patient variations may warrant production of the transannular band of the
present invention in an array of sizes and/or configurations, so that
clinical judgment may be exercised to select the appropriate implant for
a given case. Alternatively, the transannular band may be provided in an
adjustable form or a modular form so that an implant of the desired
configuration can be constructed or modified intraoperatively at the
clinical site. In a three segment embodiment, such as that illustrated in
FIGS. 24 through 27, a central segment may be provided for positioning
within the center of the flow path, or centered on the coaptive edges of
the leaflets. First and second end portions may be connected to the
central portion, for supporting the central portion relative to the
tissue anchors. First and second end portions may be provided in a
variety of lengths and curvatures, enabling construction of a relatively
customized modular implant as may be desired for a particular patient.

[0089]For example, FIG. 24 illustrates a transannular band 50 with a
central portion 64 and two gently angled arm portions 70 and 72. The
first and second ends 52 and 54 are displaced from the central portion 64
by a height, h1 and h2, respectively. In FIG. 24, h1 and h2 are about
equal and can range from about 0 mm to about 10 mm. Preferably h1 and h2
will be at least about 2 mm and will often be at least about 4 mm or 6 mm
or more, but generally no more than about 10 mm or 12 mm.

[0090]FIG. 25 illustrates a transannular band 50 with a central portion 64
and two sharply angled arm portions 70 and 72. The first and second ends
52 and 54 are displaced from the central portion 64 by a height, h1 and
h2, respectively. In FIG. 25, h1 and h2 are about equal and can range
from about 8 mm to about 12 mm. FIG. 26 illustrates a transannular band
50 with a central portion 64, a highly angled first arm 70 and a gently
angled second arm 72. The first and second ends 52 and 54 are displaced
from the central portion 64 by a height, h1 and h2, respectively. In FIG.
26, h1 is greater than h2. h1 ranges from about 6 mm to about 10 mm,
while h2 ranges from about 2 mm to about 6 mm. FIG. 27 illustrates a
transannular band 50 with a central portion 64, a gently angled first arm
70 and a highly angled second arm 72. The first and second ends 52 and 54
are displaced from the central portion 64 by a height, h1 and h2,
respectively. FIG. 27, may be a mirror image of FIG. 26.

[0091]The transannular band 50 can be made of any of a variety of
materials that are compatible with implantation within a patient's body
and which has the requisite structural integrity to support the mitral
valve leaflets. For example, suitable materials include titanium,
titanium alloys, stainless steel, stainless steel alloys, nitinol, other
metals and alloys, ceramics, and polymers such as PTFE, polycarbonate,
polypropylene HDPE, PEEK, PEBAX and the like.

[0092]In order to reduce the thrombogenicity of the transannular band 50,
the transannular band 50 can be provided with a smooth surface. In
addition, the transannular band 50 can be coated with a variety of
substances to reduce thrombogenicity. For example, the transannular band
50 can be coated with a antithrombogenic agent such as heparin, a polymer
such as PTFE, or a polymer conjugated with heparin or another
antithrombogenic agent.

[0093]As illustrated in FIGS. 28-31, the transannular band 50 is implanted
in the plane of the mitral valve annulus 28 in a patient suffering from
anterior leaflet 26 prolapse caused by the rupture 42 of the chordae
tendineae 30 attached to the anterior leaflet 26. Although a prolapsed
anterior leaflet 26 is illustrated, it should be understood that the
method described herein is also applicable for treating other types of
prolapse, such as posterior leaflet prolapse and prolapse caused by
elongated leaflets 24 and 26. The transannular band 50 can be attached to
the annulus 28 by a variety of techniques, such as sutures, anchors,
barbs, stapes, self-expanding stents, or other techniques that are known
or are apparent to those of skill in the art.

[0094]As best illustrated in FIGS. 29 and 31, the transannular band 50 is
oriented in the annulus 28 so that the transannular band 50 is positioned
approximately transversely to the coaptive edge 42 formed by the closure
of the mitral valve leaflets 24 and 26. The transannular band 50 can also
be positioned over the prolapsed portion of the anterior leaflet 26 so
that the transannular band 50 can directly support the prolapsed portion
of the anterior leaflet 24 and keep the anterior leaflet 24 above the
plane of the mitral valve annulus 28, i.e., elevated in the direction of
the ventricle, thereby preventing or reducing prolapse and mitral
regurgitation.

[0095]FIGS. 28 and 29 illustrate the effect of the transannular band 50 on
the mitral valve 18 during systole. As shown, both the anterior leaflet
24 and the posterior leaflet 26 are supported by the transannular band
during closure of the mitral valve 18. The arcuate transannular band 50
functions to keep both leaflets 24 and 26 above the plane of the annulus
28 and enables the leaflets 24 and 26 to form a coaptive edge 40.
Although a single transannular band 50 has been illustrated, in some
embodiments, multiple transannular bands 50 such as two or three or more
can be implanted across the annulus 28 to provide additional support to
the mitral valve leaflets 24 and 26.

[0096]FIGS. 30 and 31 illustrate the effect of the transannular band 50 on
the mitral valve 18 during diastole. During diastole, the mitral valve 18
opens so that blood can fill the left ventricle 16 from the left atrium
12. As best illustrated in FIG. 31, the transannular band 50 obstructs
only a small portion of the mitral valve 18 opening, and therefore, does
not cause excessive resistance to blood flow.

[0097]FIGS. 32-35 are cross-sectional side views of the mitral valve 18
with and without the support of the transannular band 50. During systole,
the mitral valve 18 closes. Without the transannular band 50, the
anterior leaflet 24 crosses the plane P defined by the mitral valve
annulus 28 and prolapses, which leads to mitral regurgitation, as shown
in FIG. 33. However, by implanting the transannular band 50 in the
annulus 28 such that the arcuate transannular band 50 arches towards the
left ventricle and the central portion 64 is displaced from the plane P,
the anterior leaflet 24 is prevented from prolapsing above the plane P
thus eliminating or reducing retrograde flow (shown in FIG. 33). The
leaflets 24 and 26 rest upon the transannular band 50 and the pressure
exerted by the blood upon the distal portion of the leaflets 24 and 26
form the coaptive edge 40. As illustrated in FIGS. 34 and 35, the
performance of the mitral valve 18 during diastole is not substantially
affected by the transannular band 50.

[0098]Although the method of implanting and positioning the transannular
band 50 has been illustrated with one embodiment of the transannular band
50, other embodiments as described above can also be used. For example,
FIG. 36 illustrates a transannular band 50 with a wider, offset coaptive
edge support portion 66 that has been implanted in the mitral valve
annulus. As shown, the coaptive edge support 66 is offset so that it
positioned to support the coaptive edge of the mitral valve 18. In
addition, the transannular band 50 can be used in conjunction with other
devices and procedures, such as a separate or integrally attached annular
or annuloplasty ring described above. In addition, the transannular band
50 can be used in conjunction with the Alfieri procedure, where the tips
of the mitral valve leaflets 24 and 26 are sutured 74 together, as shown
in FIG. 38.

[0099]Referring to FIG. 37, there is illustrated a perspective view of a
transannular band 50 having a transverse projection or support 51
extending in the direction of the ventricle. The support 51 has a width
W, which may be at least about 3 mm, and in some embodiments, at least
about 5 mm, and in other embodiments at least about 1.0 cm. The
projection 51 may be utilized without an Alfieri stitch, so that the
leaflets of the mitral valve close against opposing side walls 53 and 55
of the projection 51. The projection 51 thus helps center the closure of
the leaflets, as well as controlling the width of coaption. In addition,
the band 50 is illustrated as convex in the direction of the ventricle,
to accomplish early closure as has been discussed herein.

[0100]The transannular band 50 can be implanted via an open surgical
procedure, or alternatively, via a percutaneous procedure using a
translumenally implantable embodiment. In the translumenally implantable
embodiment, one or more transannular bands can be attached to a
self-expandable support structure, such as a self-expandable ring or
self-expandable stent having a relatively short axial length relative to
its expanded diameter. The transannular band and the compressed
self-expandable support structure are loaded into a catheter with a
retractable outer sheath which is inserted percutaneously and advanced
translumenally into or across the mitral valve. The retractable outer
sheath can be retracted to allow the self-expandable support structure to
expand against the annulus, thereby positioning the one or more
transannular bands in about the plane of the mitral annulus. Each
transannular band can be characterized by a longitudinal axis, and the
transannular band is orient in the mitral valve such that the
longitudinal axis of the transannular band in oriented transversely to
the coaptive edge of the mitral valve.

[0101]While the foregoing detailed description has set forth several
exemplary embodiments of the apparatus and methods of the present
invention, it should be understood that the above description is
illustrative only and is not limiting of the disclosed invention. It will
be appreciated that the specific dimensions and configurations disclosed
can differ from those described above, and that the methods described can
be used within any biological conduit within the body.